The accessible, easy-to-follow guide that demystifies documentation management When it comes to receiving documentation to confirm good science, U.S. and international regulators place high demands on the healthcare industry. As a result, companies developing and manufacturing therapeutic products must implement a strategy that allows them to properly manage their records and documents, since they must comply with rigorous standards and be available for regulatory review or inspection at a momentas notice. Written in a user-friendly QaA style for quick reference, Managing the Documentation Maze provides answers to 750 questions the authors encounter frequently in their roles as consultants and trainers. In simple terms, this handy guide breaks down the key components that facilitate successful document management, and shows why it needs to be a core discipline in the industry with information on: Compliance with regulations in pharmaceutical, biological, and device record keeping Electronic systems, hybrid systems, and the entire scope of documentation that companies must manage How to write and edit documents that meet regulatory compliance Making the transition to an electronic system, including how to validate and document the process Anyone responsible for managing documents in the health field will find this book to be a trusted partner in unraveling the bureaucratic web of confusion, while it initiates a plan on how to put an effective, lasting system in placeaone that will stand up to any type of scrutiny.Can We Use Our Existing System to Approve the Validation Documents for Our New E-System? Yes. You can keep the existing system operational, whether it is manual or another e-system, until you validate the new system and move your records and ... The owner is usually one of the people instrumental in bringing the system in-house and ... 11. What Is the Role of Quality Assurance in COTS CHAPTER 5 MAKING THE TRANSITION FROM HYBRID TO VALIDATED E- SYSTEM 101.
|Title||:||Managing the Documentation Maze|
|Author||:||Janet Gough, David Nettleton|
|Publisher||:||John Wiley & Sons - 2010-03-16|